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Clinical Trial Manager

IT Engagements
  • NULL, NULL
  • Remote
  • Quick Apply
7 days ago

Job Description

Greetings from IT Engagements
IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.
Job Summary
Job Title: Clinical Trial Manager
Work Location: Remote
Work Experience: 8 years
Position Summary
The Clinical Trial Manager (CTM) leads the day-to-day operational execution of Phase I IV clinical trials in strict compliance with FDA regulations, GCP, and ICH guidelines. This role acts as the central hub, cross-functionally coordinating internal teams, Contract Research Organizations (CROs), vendors, and clinical sites to keep studies on timeline, within budget, and inspection-ready.
Key Responsibilities
  • Study Execution & Governance: Direct all operational aspects across study start-up, active conduct, and close-out. Develop core trial documents, including study protocols, Informed Consent Forms (ICFs), Clinical Monitoring Plans, and operational SOPs.
  • Vendor & CRO Management: Lead the evaluation, RFP process, and performance oversight for CROs, central labs, eCOA/IRT providers, and site monitoring services. Track KPIs, review monitoring visit reports, and resolve operational bottlenecks.
  • Site Management & Patient Recruitment: Oversee site feasibility assessments, selection, activation, and investigator meetings. Design patient enrollment and retention strategies to ensure recruitment targets are hit without compromising data quality.
  • Financial & Resource Tracking: Manage multi-million-dollar study budgets, approve vendor invoices, track pass-through costs, and handle change orders.
  • Regulatory & Quality Assurance: Ensure absolute compliance with FDA 21 CFR regulations, GCP, and local IRB requirements. Maintain Trial Master File (TMF) completeness and lead audit/inspection readiness efforts.
  • Data Integrity & Cross-Functional Alignment: Partner with Data Management, Safety/Pharmacovigilance, Biostatistics, and Medical Writing to facilitate timely database locks and Clinical Study Reports (CSRs).
Required Qualifications & Education
  • Education: Bachelor's degree in Life Sciences, Nursing, or related health discipline (Master's or PharmD preferred).
  • Experience: 5+ years in clinical research operations, including at least 2 3 years of direct study management experience within a sponsor company or CRO.
  • Regulatory Expertise: In-depth knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), ICH-GCP guidelines, and ClinicalTrials.gov registry maintenance.
  • Technical Skills: Proficiency with EDC (e.g., Medidata Rave), CTMS, eTMF systems, IRT/IxRS, and Microsoft Office / Project.
  • Certifications (Preferred): SOCRA (CCRP) or ACRP (CP/CTM) certification.
Regards,
Satya
Satya@Itengagements.com

Numbers & Facts

LocationNULL, NULL (
Remote)

Skills

  • Billingunmatched
  • Biologyunmatched
  • Biostatisticsunmatched
  • Budget Managementunmatched
  • Budgetingunmatched
  • Change Requests/Ordersunmatched
  • Clinical Dataunmatched
  • Clinical Monitoringunmatched
  • Clinical Researchunmatched
  • Clinical Trialunmatched
  • Clinical Trial Managementunmatched
  • Code of Federal Regulationsunmatched
  • Contract Research Organization (CRO)unmatched
  • Cross-Functionalunmatched
  • Data Managementunmatched
  • Data Qualityunmatched
  • Electronic Data Capture (EDC)unmatched
  • Equal Credit Opportunity Act (ECOA)unmatched
  • FDA Requirementsunmatched
  • Feasibility Analysisunmatched
  • File Maintenanceunmatched
  • GCP (Good Clinical Practices)unmatched
  • ICH Regulationsunmatched
  • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
  • Informed Consentunmatched
  • Insurance Regulationsunmatched
  • Maintain Complianceunmatched
  • Medical Writingunmatched
  • Microsoft Officeunmatched
  • Microsoft Projectunmatched
  • Nursingunmatched
  • Operations Planningunmatched
  • Operations Researchunmatched
  • Performance Analysisunmatched
  • Performance Metricsunmatched
  • Pharmacovigilanceunmatched
  • Phase I Clinical Trialsunmatched
  • Phase IV Clinical Trialsunmatched
  • Process Managementunmatched
  • Quality Assuranceunmatched
  • Recruiting Strategyunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Request for Proposals (RFP)unmatched
  • Research Protocolsunmatched
  • Retention Programsunmatched
  • Site Evaluationunmatched
  • Society of Clinical Research Associates (SoCRA)unmatched
  • Standard Operating Procedures (SOP)unmatched
  • Startupunmatched
  • Time Managementunmatched

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